– Company Provides Business Update and
Fiscal Year 2009 Financial Guidance–
ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that
develops targeted anticancer therapeutics using its Tumor-Activated
Prodrug (TAP) technology, today announced financial results for the
three-month period and fiscal year ended June 30, 2008.
“The progress being made by us and our
collaborators became more visible this past year and we expect it to
gain increased momentum over the next twelve months,”
commented Mitchel Sayare, Chairman and CEO. “We’ve
reported encouraging initial clinical findings with IMGN242 and IMGN901,
and in July we advanced our third TAP compound, IMGN388, into clinical
testing. Genentech outlined a broad development plan for trastuzumab-DM1
in their last quarterly call and now expects to report the first
Phase II findings with this TAP compound next month. Our other
collaborators – sanofi-aventis, Biogen Idec
and Biotest – also have had notable product
achievements. We recently unveiled another cutting-edge expansion of our
technology portfolio – new linkers designed
specifically for multi-drug resistant cancers. We expect to report other
technology innovations in the coming year, as well as more additions to
our product portfolio.”
Recent Corporate Highlights
-
Genentech reported encouraging trastuzumab-DM1 (T-DM1) Phase I data at
the American Society of Clinical Oncology (ASCO) annual meeting in
June 2008 and in July 2008 disclosed its intention to report interim
Phase II data at the ASCO Breast Cancer Symposium in September 2008;
-
Promising clinical findings also were reported at the ASCO annual
meeting for IMGN242, in development by ImmunoGen and for AVE1642, in
development by collaborator sanofi-aventis;
-
Genentech discussed in July 2008 its intention to evaluate T-DM1 as a
first-line treatment and as a third-line treatment for HER2-positive
metastatic breast cancer in Phase II clinical trials, and that it
plans to make a Phase III decision in 2008 related to potentially also
evaluating T-DM1 as a second-line treatment for this cancer;
-
ImmunoGen further refined the next steps in the clinical evaluation of
IMGN901 for the treatment of multiple myeloma;
-
TAP compounds IMGN388 and BIIB015 advanced into clinical testing by
ImmunoGen and by its collaborator Biogen Idec, respectively;
-
ImmunoGen unveiled innovations in its technology expected to further
expand the opportunity for TAP compounds; and
-
The Company raised $25 million in June 2008 through the sale of common
stock to a single buyer.
Financial Results
For the three-month period ended June 30, 2008, ImmunoGen reported a net
loss of $11.9 million, or $0.27 per basic and diluted share, compared to
a net loss of $4.5 million, or $0.11 per basic and diluted share, for
the same period last year. For the fiscal year ended June 30, 2008,
ImmunoGen reported a net loss of $32.0 million, or $0.75 per basic and
diluted share, compared to a net loss of $19.0 million, or $0.45 per
basic and diluted share, for the fiscal year ended June 30, 2007.
Revenues for the three-month period ended June 30, 2008 were $4.5
million, compared to $8.5 million for the same quarter last year. Fourth
quarter fiscal 2008 revenues include $3.4 million of research and
development support fees, compared to $6.8 million for the same period
last year. Research and development support fees primarily represent
funding earned pursuant to ImmunoGen’s
discovery, development and commercialization collaboration with
sanofi-aventis and, to a lesser extent, funding earned under the Company’s
development and license agreements with other of its collaborative
partners. The fifth and final contract year with sanofi-aventis began in
September 2007 and provides for reduced research and development support
fees compared with the previous contract year as ongoing development
activity is transitioned to sanofi-aventis. Fourth quarter fiscal 2008
revenues also include $1.1 million of license and milestone fees,
compared to $1.3 million for the same quarter last year and $49,000 of
clinical material reimbursement, compared to $0.5 million for the same
quarter last year. ImmunoGen manufactures clinical materials on behalf
of its collaborators and, as needed, also supplies its collaborators
with the Company’s cytotoxic agents (DM1 and
DM4) in support of their manufacturing and development efforts, and
earns clinical material reimbursement revenue with the supply of these
materials to those collaborators.
Revenues for the fiscal year ended June 30, 2008 were $40.2 million,
compared to $38.2 million for the fiscal year ended June 30, 2007.
Revenues for the 2008 fiscal year include $15.0 million of research and
development support fees, compared to $25.5 million for the same period
last year. The significant decrease is primarily due to reduced research
and development support fees earned pursuant to the discovery,
development and commercialization collaboration with sanofi-aventis, as
noted above. During the 2007 fiscal year, ImmunoGen also earned more in
research and development support fees pursuant to agreements with other
of its collaborators as compared to the current year. Revenues for the
2008 fiscal year include $13.2 million of license and milestone fees,
compared to $7.6 million for fiscal 2007. Included in license and
milestone fees for the 2008 fiscal year is a $5.0 million milestone
related to the initiation of Phase II clinical testing of T-DM1 by
Genentech, a $1.5 million milestone related to the submission by Biogen
Idec of the Investigational New Drug (IND) application for BIIB015 to
the US Food and Drug Administration (FDA) and a $1.0 million milestone
related to the initiation of Phase I testing of SAR3419 by
sanofi-aventis. Included in license and milestone fees for the 2007
fiscal year is a $2.0 million milestone payment related to the
initiation of Phase I testing of AVE1642 by sanofi-aventis. Revenues for
the 2008 fiscal year also include $12.1 million of clinical material
reimbursement, compared to $5.1 million for fiscal 2007. The greater
clinical material reimbursement revenue for fiscal 2008 compared with
fiscal 2007 is primarily due to $5.0 million in revenue recognized by
the Company for providing one of its cytotoxic agents to a collaborator
as well as to an increase in the amount of clinical material supplied to
collaborators.
Operating expenses for the three-month period ended June 30, 2008 were
$16.5 million, compared to $13.8 million in the same period last year.
The operating expenses in the fourth quarter of fiscal 2008 include
research and development expenses of $12.7 million, compared to $11.0
million for the same quarter last year. The increase in research and
development expenses for the quarter ended June 30, 2008 versus the
prior-year period is primarily due to increased antibody supply costs
and also to development costs incurred with contract manufacturing
organizations related to the potential production of later-stage
materials. Clinical trial costs also increased by $0.9 million during
the 2008 period compared to the same period last year due to costs
associated with the start of IMGN388 clinical testing. This includes a
$0.5 million milestone expense ImmunoGen incurred to a third party
related to the advancement of IMGN388 to clinical stage. Fourth quarter
fiscal 2008 operating expenses also include general and administrative
expenses of $3.7 million, compared to $2.8 million for the same quarter
last year. General and administrative expenses increased primarily as a
result of increases in patent costs, personnel costs and expenses
related to the move of the Company to Waltham, MA.
Operating expenses for the fiscal year ended June 30, 2008 were $74.4
million, compared to $60.4 million for the fiscal year ended June 30,
2007. Included in the operating expenses for fiscal 2008 are research
and development expenses of $60.0 million, compared to $49.4 million for
the 2007 fiscal year. The increase in research and development expense
for fiscal 2008 compared to the prior year is primarily due to the cost
of supplying one of ImmunoGen's cytotoxic agents to a collaborator
during the year, as previously discussed, and the Company's purchase of
DM1/DM4 during the third quarter. Operating expenses for the 2008 fiscal
year also include general and administrative expenses of $14.3 million,
compared to $11.0 million for the 2007 fiscal year. During fiscal 2008,
the Company recognized $1.5 million of expense related to the rental of
laboratory and office space in Waltham prior to occupying this space in
late March 2008, as well as $0.8 million of move-related expenses,
classifying such as general and administrative expenses. General and
administrative expenses also were greater due to increases in costs
associated with personnel and patents.
Other income, net, consisting primarily of interest income, losses
realized on investments due to impairment and gains recognized on
forward contracts, was $0.1 million in the fourth quarter of fiscal
2008, compared to $0.8 million for the same period last year and was
$2.1 million in the fiscal year ended June 30, 2008, compared to
$3.3 million for the fiscal year ended June 30, 2007. Included in other
income, net, for the fourth quarter of fiscal 2008 and the year ended
fiscal 2008 was $0.3 million and $0.5 million, respectively, of
impairment charges on investments. No similar charges were incurred
during fiscal 2007.
ImmunoGen had approximately $47.9 million in cash and marketable
securities as of June 30, 2008 – inclusive of
$25 million raised in June 2008 through the sale of common equity to a
single buyer – compared with $59.7 million as
of June 30, 2007 and had no debt outstanding in either period. During
fiscal 2008, cash used in operations was $20.2 million, compared to
$15.8 million in fiscal 2007. Capital expenditures were $18.0 million
and $2.0 million for the fiscal years ended June 30, 2008 and 2007,
respectively. Capital expenditures for the current year include $3.7
million for improvement of the Company’s
capabilities at its manufacturing plant in Norwood, MA and $10.3 million
to build out the laboratory and office space at the Waltham facility
occupied by ImmunoGen in late March 2008. The $10.3 million of leasehold
improvements are being paid by the landlord of the Waltham facility,
with such reimbursements recorded as a benefit to cash used in
operations.
Financial Guidance
ImmunoGen expects the net loss for its fiscal year ending June 30, 2009
to be between $37-$40 million, cash used in operations to be between
$20-$23 million and capital expenditures of $1-$3 million.
"In our 2009 fiscal year, we expect to have lower cash use than in 2008
even though we’ll be putting more resources
behind our own compounds," noted Daniel Junius, President and Chief
Operating Officer. “In this fiscal year, we
anticipate that cash used in operations will be at a level similar to
our 2008 fiscal year and that our capital expenditures will be
substantially lower. The funded research portion of our collaboration
with sanofi-aventis will conclude as scheduled at the end of this month,
causing an expected decrease in our total projected revenues and thus an
increase in our projected net loss. The impact of the conclusion of this
funding on our cash position, however, is expected to be offset by lower
operating expenses, reduced capital spending and increases in other
collaborator activity.”
Collaboration with sanofi-aventis
As previously disclosed, the research portion of Company’s
collaboration with sanofi-aventis is scheduled to conclude on August 31,
2008 as no further extension is allowed under the agreement entered into
by the companies in July 2003.
After August 31, 2008, ImmunoGen will continue to be entitled to receive
milestone payments and royalties on the many compounds developed under
this collaboration, to receive manufacturing payments on materials
produced on behalf of sanofi-aventis, to receive financial compensation
for further research conducted on behalf of sanofi-aventis and to have
the co-promotion rights established in the 2003 agreement.
Sanofi-aventis’ right to license
non-exclusive use of ImmunoGen’s humanization
technology for targets not included in the collaboration also remains in
effect after August 31, 2008. However, its option to enter into an
agreement with ImmunoGen for the right to test the Company’s
TAP technology with antibodies to targets not included in the
collaboration will expire on August 31, 2008 if not exercised before
then.
Update on ImmunoGen Clinical-Stage Compounds
IMGN901
This TAP compound is in development for the treatment of CD56-expressing
multiple myeloma and solid tumors. Three IMGN901 trials are underway –
Study 001 in small-cell lung cancer and the dose-escalation trials Study
002 and Study 003 in CD56-expressing solid tumors and multiple myeloma,
respectively.
-
ImmunoGen expects to report additional clinical findings for both
multiple myeloma and solid tumors in the fourth quarter of 2008.
-
Once the maximum tolerated dose (MTD) is established in Study 003, up
to 15 patients will be treated at this MTD to gain additional
information on the activity of IMGN901 as monotherapy against highly
treatment-resistant multiple myeloma.
-
In light of the market trend toward treating multiple myeloma with
combination therapy, ImmunoGen plans to initiate a Phase I/II trial to
evaluate IMGN901 in combination with an approved therapeutic after its
MTD as monotherapy is established.
IMGN242
IMGN242 is in Phase II testing (Study 102) for the treatment of
CanAg-expressing gastric cancer. Additional cancers that express the
target of this TAP compound include pancreatic, colorectal and other
gastrointestinal tumors. The poster presented at the ASCO annual meeting
in June 2008 described one of the first patients treated with IMGN242 in
Study 102 who had a marked response to treatment. Patient enrollment is
ongoing in this study.
-
The Company expects to report additional findings with IMGN242 in the
fourth quarter of 2008.
-
ImmunoGen intends to complete enrollment of the first 23 patients in
this study during its fiscal year ending June 30, 2009.
IMGN388
Patient dosing with IMGN388 began in early July 2008. The integrin
target for this TAP compound is found on many types of solid tumors –
melanomas, sarcomas and numerous carcinomas –
and also on endothelial cells in the process of forming the new blood
vessels that all solid tumors need to grow.
-
ImmunoGen expects to report initial Phase I clinical findings in 2009.
Update on Collaborator Clinical-Stage Compounds
Genentech: T-DM1
T-DM1 comprises ImmunoGen’s DM1 cell-killing
agent linked to Genentech’s anti-HER2
antibody, trastuzumab. Genentech reported encouraging T-DM1 Phase I data
at the ASCO annual meeting in June 2008. T-DM1 is currently in Phase II
testing for the treatment of HER2-expressing metastatic breast cancer.
-
Genentech has disclosed that patient enrollment has completed in the
Phase II study that was started in mid-2007 to evaluate T-DM1 in
patients whose HER2-expressing metastatic breast cancer progressed on
HER2-directed therapy (“second-line plus”
treatment). Genentech has reported that it expects to submit an
abstract for presentation of interim data from this study at the ASCO
Breast Cancer Symposium being held September 5-7, 2008 in Washington,
DC.
-
Genentech has reported that it plans to initiate two additional T-DM1
Phase II trials in the second half of 2008. One of these trials is
designed to evaluate T-DM1 as monotherapy compared with Herceptin
(trastuzumab) plus docetaxel as a first-line treatment for
HER2-positive metastatic breast cancer. The other trial is to evaluate
T-DM1 as a third-line treatment for this cancer. Genentech has
disclosed that if the results of the third-line study are compelling,
the company will discuss an earlier approval pathway with the FDA.
-
Genentech has disclosed that it plans to make a Phase III decision in
2008 related to potentially also evaluating T-DM1 as a second-line
treatment for HER2-positive metastatic breast cancer.
sanofi-aventis: AVE1642, AVE9633, SAR3419
AVE1642 is a non-conjugated or “naked”
antibody in development by sanofi-aventis for the treatment of solid and
liquid tumors. This compound is designed for use in combination with
chemotherapy, and the first clinical data on its safety and activity
with a chemotherapeutic agent – docetaxel –
were reported at the ASCO meeting in June 2008. AVE1642 was found to be
well tolerated and evidence of anticancer activity was reported. Trials
are planned or underway to study AVE1642 in combination with an array of
chemotherapy agents for the treatment of many different types of cancers.
The TAP compounds AVE9633 and SAR3419 are in Phase I testing for the
treatment of acute myeloid leukemia and non-Hodgkin’s
lymphoma, respectively.
-
ImmunoGen expects the first SAR3419 clinical data to be reported in
late 2008.
Biogen Idec: BIIB015
This TAP compound advanced into clinical testing in mid-2008 and is a
potential new treatment for solid tumors.
Biotest: BT062
The TAP compound BT062 is expected to begin clinical testing this summer
and is a potential new treatment for multiple myeloma.
Technology Update
ImmunoGen’s TAP technology is attracting
attention because of the activity seen against treatment-resistant
tumors and also because of the excellent tolerability documented at
doses substantially greater than those able to be administered with
other technologies. ImmunoGen credits these benefits to the qualities of
its cell-killing agents and linkers.
ImmunoGen recently unveiled additional linkers developed by the Company
to provide enhanced activity against multi-drug resistant cancer cells.
These proprietary linkers also are expected to expand the opportunity
for TAP compounds for targets that are expressed at a low density on the
cancer cell. ImmunoGen is committed to maintaining its leadership
position in its field.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using its
expertise in cancer biology, monoclonal antibodies and the creation and
attachment of potent cell-killing agents. The Company’s
TAP technology uses antibodies to deliver one of ImmunoGen’s
proprietary cell-killing agents specifically to cancer targets. In
addition to the Company’s proprietary
clinical pipeline, ImmunoGen collaborators Genentech, sanofi-aventis and
Biogen Idec also are testing TAP compounds in the clinic, and a naked
antibody is in clinical trials through the Company’s
collaboration with sanofi-aventis.
This press release includes forward-looking statements based on
management’s current expectations. These
statements include, but are not limited to, ImmunoGen’s
expectations related to: its expected net loss, cash used in operations
and capital expenditures in its 2009 fiscal year and the anticipated
changes in operating expenses, capital spending, and collaborator
activity; the Company’s and its collaboration
partners’ clinical trial activity and
presentation of clinical data; the Company’s
technology innovations; the momentum of progress over the next twelve
months; and to other events related to the Company’s
product portfolio. For these statements, ImmunoGen claims the protection
of the safe harbor for forward-looking statements provided by the
Private Securities Litigation Reform Act of 1995. Various factors could
cause ImmunoGen’s actual results to differ
materially from those discussed or implied in the forward-looking
statements and you are cautioned not to place undue reliance on these
forward-looking statements, which are current only as of the date of
this release. Factors that could cause future results to differ
materially from such expectations include, but are not limited to: the
outcome of ImmunoGen’s research and clinical
development processes; the outcome of ImmunoGen’s
collaboration partners’ research and clinical
development processes; the difficulties inherent in the development of
novel pharmaceuticals, including uncertainties as to the timing, expense
and results of preclinical studies and clinical trials; ImmunoGen’s
ability to financially support its product programs; ImmunoGen’s
dependence on collaborative partners; and other factors more fully
described in ImmunoGen’s Annual Report on
Form 10-K for the fiscal year ended June 30, 2007 and other reports
filed with the Securities and Exchange Commission.
|
IMMUNOGEN, INC.
|
|
SELECTED FINANCIAL INFORMATION
|
|
(in thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
June 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and marketable securities
|
|
$
|
47,871
|
|
|
$
|
59,700
|
|
|
|
|
|
|
|
|
|
Other assets
|
|
|
35,467
|
|
|
|
20,721
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
83,338
|
|
|
$
|
80,421
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
$
|
10,386
|
|
|
$
|
14,288
|
|
|
|
|
|
|
|
|
|
Long-term portion of deferred revenue and other long-term liabilities
|
|
|
17,653
|
|
|
|
7,732
|
|
|
|
|
|
|
|
|
|
Shareholders' equity
|
|
|
55,299
|
|
|
|
58,401
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders' equity
|
|
$
|
83,338
|
|
|
$
|
80,421
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Year Ended
|
|
|
|
|
|
|
|
|
June 30,
|
|
June 30,
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
|
2007
|
|
|
|
2008
|
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development support
|
|
$
|
3,374
|
|
|
$
|
6,803
|
|
|
$
|
15,035
|
|
|
$
|
25,486
|
|
|
|
License and milestone fees
|
|
|
1,060
|
|
|
|
1,254
|
|
|
|
13,156
|
|
|
|
7,585
|
|
|
|
Clinical materials reimbursement
|
|
|
49
|
|
|
|
477
|
|
|
|
12,058
|
|
|
|
5,141
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
|
|
|
4,483
|
|
|
|
8,534
|
|
|
|
40,249
|
|
|
|
38,212
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
12,739
|
|
|
|
11,028
|
|
|
|
60,013
|
|
|
|
49,409
|
|
|
|
General and administrative
|
|
|
3,722
|
|
|
|
2,818
|
|
|
|
14,348
|
|
|
|
11,029
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
16,461
|
|
|
|
13,846
|
|
|
|
74,361
|
|
|
|
60,438
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
|
|
(11,978
|
)
|
|
|
(5,312
|
)
|
|
|
(34,112
|
)
|
|
|
(22,226
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net
|
|
|
55
|
|
|
|
790
|
|
|
|
2,119
|
|
|
|
3,274
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before taxes
|
|
|
|
|
(11,923
|
)
|
|
|
(4,522
|
)
|
|
|
(31,993
|
)
|
|
|
(18,952
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense
|
|
|
|
5
|
|
|
|
7
|
|
|
|
27
|
|
|
|
35
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
$
|
(11,928
|
)
|
|
$
|
(4,529
|
)
|
|
$
|
(32,020
|
)
|
|
$
|
(18,987
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted
|
|
$
|
(0.27
|
)
|
|
$
|
(0.11
|
)
|
|
$
|
(0.75
|
)
|
|
$
|
(0.45
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average common shares outstanding, basic and diluted
|
|
|
43,863
|
|
|
|
42,282
|
|
|
|
42,969
|
|
|
|
41,759
|
|
Investors:
ImmunoGen, Inc.
Carol Hausner, 781-895-0600
Executive
Director, Investor Relations and
Corporate Communications
info@immunogen.com
or
Media:
KMorrisPR
Kathryn
Morris, 845-635-9828
Kathryn@kmorrispr.com